ObaapaVita Trial: Evaluating impact of low dose weekly Vitamin A Supplementation on Maternal Mortality in Ghana

Overview:
This is a double blind placebo controlled trial to evaluate the impact on maternal mortality (and all cause adult female mortality) of weekly low dose vitamin A supplements to women of child bearing age. At these doses vitamin A is known to be safe. All the approx 100,000 women aged 15-45, from 4 continguous districts in Brong Ahafo Region, central Ghana have been recruited. Weekly vitamin A/placebo supplementation is being delivered through regular 4-weekly follow-up visits, and is supported by a range of IEC activities promoting capsule taking.

Women participating will have approximately 55,000 births and be followed up for a range of outcomes including female and maternal mortality, maternal morbidity, and fetal and infant mortality. The study is statistically capable of showing a 33% reduction in maternal mortality from a baseline maternal mortality ratio of 400. Women participating in the trial will benefit by receiving treatment for any problems detected during the study. Results from the trial will help identify the potential role of Vitamin A in the Safe Motherhood Initiative and show mechanisms of action. If successful, it should provide a new intervention for reducing maternal mortality in Ghana, and worldwide.

Rationale:
Vitamin A deficiency is a well-recognised problem affecting many children and pregnant women in developing countries. Severe deficiency causes eye damage, manifested as night blindness and xerophthalmia, which if untreated can lead to permanent blindness. In addition, vitamin A is crucial for effective immune-system functioning. Interventions to improve vitamin A intake include dietary modification, home gardens, supplementation, fortification and plant breeding.

The benefits of intervening to improve the vitamin A status of young children are well recognised; a meta-analysis of eight randomised controlled trials of vitamin A supplementation showed an average mortality reduction of 23% among children aged 6 months to 5 years. Additionally, vitamin A supplements as part of measles case management can reduce the case fatality rate by more than 50%.

In contrast, the benefits of improving the vitamin A status of pregnant women has been little studied. In 1999, a study in Nepal reported that Vitamin A supplementation reduced maternal mortality by 43%. If the effect is real, Vitamin A supplementation could become an important part of Safe Motherhood programmes. If the effect is not real, there is a danger that other Safe Motherhood interventions could be abandoned in favour of Vitamin A. Maternal ill-health is the leading contributor to the disease burden of women, and over half a million women die each year of maternal causes.